Penile prosthesis

ABSTRACT

A male impotence treatment apparatus comprises an adjustable prosthesis device implanted in an impotent patient. The prosthesis device engages the corpus cavernosum or penile tissue of the patient to provide flaccid or erect state of the penis. An implanted adjustment device is adapted to adjust the prosthesis such that the penis can be temporarily erected. The prosthesis is preferably controlled with a remote control and an implanted powered operation device, which may include servo means, operates the adjustment device.

The present invention relates to a male sexual impotence treatmentapparatus, comprising an adjustable prosthesis device implantable in thecorpora cavernosa or other parts of a male impotent patient's peniletissue, an implantable adjustment device for adjusting the prosthesisdevice to temporarily achieve erect status of the penis, and animplantable operation device for operating the adjustment device.

Male sexual impotence is a widespread problem. Many different solutionsto this problem have been tried. One solution to achieve erection is torestrict the blood flow leaving the penis.

For example U.S. Pat. No. 4,828,990 discloses two hydraulic operatedinflatable cuffs wrapped around respective crura. It is difficult to getsuch a device to work and therefore it is often combined with a vacuumdevice to achieve erection and to be able to maintain the erect state ofthe penis by activating the cuffs around the crura with hydraulic fluid.

Another example of this solution is U.S. Pat. No. 4,828,544, whichdiscloses an artificial fistula system Surgically implanted andproviding a primary fistula the femoral artery and the femoral vein anda secondary fistula for leading blood from the primary fistula to thepenis. The balloon is in fluid connection with a manually operablecompressible reservoir implanted in the scrotum of the patient. Onedisadvantage with this system is that it requires delicate surgery.Another disadvantage, to such a solution, is the fact that the venousblood vessel system is rather complex and it is difficult to restrictthe vein plexa.

Another currently used system is to replace the corpus cavernosum in thepenis with a hydraulic inflatable contractable silicon prosthesis thusimplanted in the penis. The system is normally in fluid connection withthe reservoir implanted in the scrotum. By manual pumping action theprosthesis is filled with fluid from the reservoir to effect erectpenile state or is emptied of fluid which returns the reservoir toeffect flacid penile state.

There are several other prior penile prosthesis disclosed in for exampleU.S. Pat. Nos. 3,855,122, 3,954,102, 4,009,711, 4,201,202, 4,235,222,4,318,396, 5,250,020 and 4,424,807.

One disadvantage with this system is that hard fibrosis is createdaround the reservoir over time and may cause malfunction of pumpingcomponents. Thus, the created fibrosis will sooner or later become ahard fibrotic layer which may make it difficult to pump the reservoir.Yet, further disadvantage is that the manual pumping of the reservoirinvolves a risk of fluid leaking from the hydraulic system. Furthermoreit is a rather complicated task to mechanically manually pump thereservoir when erection is needed. Non-return valves of the system oftencauses malfunction.

Yet another solution is to inject a substance in the penile vein systemto achieve erection. However, injections are painful and complicated forthe patient.

A prime object of the invention is to provide a male impotence treatmentpenile prosthesis, which does not require manual manipulation of acombined reservoir/pump mechanism as in prior art placed in the scrotumof the patient.

A further object of the present invention is to provide a male impotencetreatment prosthesis in which the risk of malfunction of the device orliquid leakage within the patient's body is substantially reduced.

Another object of the invention is to provide a male impotence treatmentpenile prosthesis, which does not require complicated surgery.

Yet another object of the invention is to provide a male impotencetreatment penile prosthesis, which may be conveniently controlled by thepatient with a remote control.

Yet another object of the invention is to provide male sexual impotencetreatment penile prosthesis, which does not require a use of aninjection needle.

These objects are obtained by an apparatus of the kind describedinitially characterised in that the operation device comprises a poweredoperation device capable of performing a reversible function and/or aservo means and/or a hydraulic system devoid of any non-return valve.

In accordance with another aspect of the invention, the above objectsare obtained by a male sexual impotence treatment apparatus, comprisingan adjustable prosthesis device implantable in the corpora cavernosa orother parts of a male impotent patient's penile tissue, an implantablehydraulic adjustment device for adjusting the prosthesis device totemporarily achieve erect status of the penis, an implantable operationdevice for operating the hydraulic adjustment device, a reservoirimplantable in the patient and containing hydraulic fluid, and a conduitproviding fluid connection between the reservoir and the hydraulicadjustment device, characterised in that the operation device is adaptedto operate the hydraulic adjustment device by distributing hydraulicfluid through the conduit between the reservoir and the hydraulicadjustment device, the conduit and hydraulic adjustment device beingdevoid of any non-return valve to permit free flow of hydraulic fluid inboth directions in the conduit.

The expression “powered” should be understood as energised witheverything without manual force, preferably electric energy. Theadjustment device is operated in a non-manual manner. The expression“non-manual manner” should be understood to mean that the adjustmentdevice is not operated by manually touching subcutaneously implantedcomponents of the apparatus or not manipulated by touching the skin ofthe patient. Thus, as opposed to prior practice when treating impotence,the adjustment device of the invention is not operated by manual forces,such as by manually compressing a fluid containing balloon implanted inthe scrotum or in the region of labia majora. Of course, manualmanipulation of a subcutaneous start button or the like for activatingthe powered operation device is permitted within the scope of thepresent invention.

Alternatively, or in combination with a powered operation device, theservo means may be used, which enables manual manipulation without needfor strong manipulation forces. The servo means may comprise hydraulicmeans, electric control means, magnetic means, or mechanical means,which may be activated by manual manipulating means. Using a servosystem will save the use of force when adjusting the adjustment device,which may be of importance in many applications.

The term “servo means” encompasses the normal definition of a servomechanism, i.e. an automatic device that controls large amounts of powerby means of very small amounts of power, but may alternatively oradditionally encompass the definition of a mechanism that transfers aweak force acting on a moving element having a long stroke into a strongforce acting on another moving element having a short stroke. The servomeans may comprise a motor, preferably an electric motor, which may bereversible and/or include a gearing.

In accordance with a main embodiment of the invention, the apparatuscomprises a reservoir, preferably containing a predetermined amount ofhydraulic fluid, also implantable in the patient, wherein the operationdevice, suitably electrically powered, operates the adjustment device byusing the hydraulic fluid of the reservoir.

The adjustment device may comprise an expandable cavity in theprosthesis device, wherein the penis is erected upon expansion of thecavity and released upon contraction of the cavity. In this embodimentthe operation device is adapted to distribute hydraulic fluid from thereservoir to expand the cavity, and from the cavity to the reservoir tocontract the cavity.

A fluid distribution tube may readily be connected between the reservoirand the cavity in a manner so that the tube does not interfere withother implanted components of the apparatus.

Preferably, the reservoir defines a chamber for the predetermined amountof fluid and the operation device changes the volume of the chamber. Theoperation device suitably comprises first and second wall portions ofthe reservoir and is adapted to provide relative displacement betweenthe first and second wall portions of the reservoir, in order to changethe volume of the chamber.

The operation device may be adapted to provide said relativedisplacement in response to the pressure in the reservoir. Suitably, theoperation device comprises a pressure controlled hydraulic operationdevice. For safety, an alarm may be provided for generating an alarmsignal in response to the lapse of a predetermined time period duringwhich the pressure controlling the hydraulic operation device exceeds apredetermined high value.

Suitably, the operation device is adapted to distribute fluid from thereservoir to the cavity of the restriction member in response to apredetermined first displacement of the first wall portion of thereservoir relative to the second wall portion of the reservoir and maydistribute fluid from the cavity to the reservoir in response to apredetermined second displacement of the first wall portion relative tothe second wall portion.

The first and second wall portions of the reservoir may be displaceablerelative to each other by a magnetic, hydraulic, or electric powermeans, such as an electric motor. In this embodiment no pump is used,only the volume of the reservoir is varied. This is of great advantagecompared to the solution described below when the operation devicecomprises a pump used to pump fluid between the reservoir and theadjustment device because there is no need for a non-return valve and itis still possible to have fluid going both to and from the reservoir.Thus, the significant risk of malfunction when using such a non-returnvalve implanted in the patient is eliminated.

The operation device may comprise hydraulic means and a fluid conduitextending between the hydraulic means and the adjustment device. Thehydraulic means and conduit are devoid of any non-return valve. Thereservoir may form part of the conduit and a fluid chamber with avariable volume. The operation device may distribute fluid from thefluid chamber to the adjustment device by reduction of the volume of thechamber and withdraw fluid from the adjustment device by expansion ofthe volume of the chamber. The operation device preferably comprises amotor for moving a movable wall of the reservoir for changing the volumeof the chamber. Any kind of motor could be used for the differentoperations as well as wireless remote solutions for controlling theoperations.

The restriction device preferably is operable to perform a reversiblefunction and accordingly there is a reversing device implantable in thepatient for reversing the function performed by the restriction device.Such a reversing function preferably involves the status of the flaccidor erected penis, preferable to change steplessly with a preselectedvalue that is satisfactory for the patient. In this connection, thecontrol device suitably controls the reversing device, which may includea switch, to reverse the function performed by the restriction device.The reversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

Where the operation device comprises a motor, the reversing device isadapted to reverse the motor.

In accordance with another particular embodiment of the invention, theoperation device comprises a pump for pumping fluid between thereservoir and the adjustment device. A mechanical solution is proposedin which it is possible to pump fluid from the reservoir to theadjustment device and vice versa just by pushing an activation member inone direction. The pump preferably comprises a first activation memberfor activating the pump to pump fluid from the reservoir to theadjustment device, and a second activation member for activating thepump to pump fluid from the adjustment device to the reservoir. At leastone of the first and second activation members may be operable by manualmanipulation, preferably to permit manual pushing, pulling or rotationthereof in one direction, or by a device powered magnetically,hydraulically, or electrically (e.g. by an electric motor), or beoperable by a combination of these methods. Suitably, at least one ofthe activation members may be adapted to operate when subjected to anexternal pressure exceeding a predetermined magnitude.

Another alternative is a pump pumping in only one direction and anadjustable valve to change the direction of fluid to either increase ordecrease the amount of fluid in the reservoir. This valve may bemanipulated either manually, mechanically, magnetically, orhydraulically.

The main embodiment of the invention described above including thereservoir may alternatively be equipped with a servo means comprising areverse servo. The term “reverse servo” is to be understood as amechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on another moving elementhaving a long stroke; i.e. the reverse function of the above-definedalternative mechanism of a normal servo mechanism. A first closedhydraulic system that controls another closed hydraulic system in whichhydraulic means of the adjustment device is incorporated may be used.Minor changes in the amount of fluid in a smaller reservoir of the firstsystem could then be transferred by the reverse servo into major changesin the amount of fluid in a larger reservoir in the second system. Inconsequence, the change of volume in the larger reservoir of the secondsystem affects the hydraulic means of the adjustment device. Forexample, a short stroke that decreases the volume of the smallerreservoir will cause the larger reservoir to supply the adjustmentdevice with a large amount of hydraulic fluid, which in turn results ina long mechanical adjustment stroke on the restriction device.

The great advantage of using such a reverse servo is that the largervolume system could be placed inside the abdomen or retroperitoneumwhere there is more space and still it would be possible to use manualmanipulation means of the smaller system subcutaneously. The smallerreservoir could be controlled directly or indirectly by a fluid supplymeans. The fluid supply means may include another small reservoir, whichmay be placed subcutaneously and may be activated by manual manipulationmeans. Both the normal servo means and the specific reverse servo may beused in connection with all of the various components and solutionsdescribed in the present specification.

Thus, the reverse servo may be adapted to provide relative displacementbetween the first and second wall portions of the reservoir, suitably inresponse to the pressure in the reservoir, in order to change the volumeof the chamber of the reservoir.

Generally, the servo means, including the reverse servo, comprises apressure controlled servo means. The alarm mentioned above mayalternatively be adapted to generate an alarm signal in response to thelapse of a predetermined time period during which the pressurecontrolling the servo means exceeds a predetermined high value.

The reverse servo may comprise magnetic means, electric means or manualmanipulation means or a combination thereof. Preferably, however, thereverse servo comprises hydraulic means.

In accordance with a particular embodiment of the invention, the reverseservo further comprises a servo reservoir defining a chamber containingservo fluid, and the operation device comprise first and second wallportions of the servo reservoir, which are displaceable relative to eachother to change the volume of the chamber of the servo reservoir. Thefirst and second wall portions of the servo reservoir may bedisplaceable relative to each other by magnetic means, hydraulic means,or electric control means.

Where the reverse servo comprises hydraulic means it may furthercomprise a fluid supply reservoir connected to the servo reservoir in aclosed system and containing a further predetermined amount of fluid.The fluid supply reservoir defines a chamber for the furtherpredetermined amount of fluid and the operation device is adapted tochange the volume of the chamber and thereby control the amount of fluidin the servo reservoir. The fluid supply reservoir comprises first andsecond wall portions, which are displaceable relative to each other tochange the volume of the chamber of the fluid supply reservoir.Suitably, the fluid supply reservoir increases the amount of fluid inthe servo reservoir in response to a predetermined first displacement ofthe first wall portion of the fluid supply reservoir relative to thesecond wall portion of the fluid supply reservoir and decreases theamount of fluid in the servo reservoir in response to a predeterminedsecond displacement of the first wall portion of the fluid supplyreservoir relative to the second wall portion of the fluid supplyreservoir.

In accordance with an embodiment of the invention, the adjustment devicecomprises a hydraulic adjustment device, and an implantable reservoircontaining a predetermined amount of hydraulic fluid and a conduitproviding fluid connection between the reservoir and the hydraulicadjustment device are provided. The operation device is adapted tooperate the hydraulic adjustment device by distributing hydraulic fluidthrough the conduit between the reservoir and the hydraulic adjustmentdevice, wherein the conduit and hydraulic adjustment device are devoidof any non-return valve to permit free flow of hydraulic fluid in bothdirections in the conduit. Preferably, the reservoir forms a fluidchamber with a variable volume, and the operation device is adapted todistribute fluid from the chamber to the adjustment device by reductionof the volume of the chamber and to withdraw fluid from the adjustmentdevice by expansion of the volume of the chamber. The operation devicemay, comprise a motor or a pump. Alternatively, the operation device maycomprise a movable wall of the reservoir for changing the volume of thechamber. For example, the operation device may be adapted to change thevolume of the chamber by moving the movable wall in response to thepressure in the chamber.

In the above embodiments including a reservoir for hydraulic fluid aninjection port may be provided for subcutaneous implantation in thepatient to be in fluid communication with the chamber of the reservoir.The injection port may be integrated in the reservoir. Such an injectionport may be provided for enabling, normally single, once-and-for-all,calibration of the amount of fluid in the hydraulic system used.

In the various embodiments hereinafter described the prosthesis devicegenerally forms an implant in the corpus cavernosum. However, theprosthesis device may take a variety of different shapes. Alternativelythe prosthesis member is flexible and elongated, and the adjustmentdevice is adapted to pull a first portion of the flexible prosthesismember from a second portion of the flexible prosthesis member toachieve an erected status of the penis, and to move the first and secondportion towards each other to achieve a flaccid status the penis.

The prosthesis device may comprise an elongated prosthesis member andforming means for forming the prosthesis member into an implant in thecorpora cavernosa, whereby the adjustment device is adapted to adjustthe prosthesis member to change the size or length of the corporacavernosa implant.

The forming means may form the prosthesis member into a predeterminedsize or a size selected from several predetermined sizes.

The adjustment device may be adapted to change the size of theprosthesis such that the outer circumferential confinement surface ofthe prosthesis member is either changed or unchanged.

In the embodiments described the adjustment device may eithermechanically or hydraulically adjust the prosthesis device, whereapplicable. It should be noted that the operation device mightmechanically or hydraulically operate the adjustment deviceirrespectively of whether the adjustment device is adapted to adjust therestriction device mechanically or hydraulically. The adjustment devicemay also be either inflatable or non-inflatable.

When the prosthesis further comprises a corpus cavernosum implant, theprosthesis device may be adapted to bend a portion of the corporacavernosa implant.

In this embodiment the prosthesis device comprises at least one bendingmember and, wherein the corpora cavernosa implant is positioned inengagement with the bending member, and the adjustment device is adaptedto move the bending members when the erected status of the penis shouldbe achieved or released.

The adjustment device may also be adapted to rotate a portion of theprosthesis device. The adjustment device is then adapted to rotate aportion of the prosthesis device when the erected status of the penisshould be achieved or released.

All embodiments according to the invention may be controlled by awireless remote control.

In accordance with an advantageous embodiment of the invention, there isprovided a wireless remote control for non-invasively controlling theoperation device. The remote control may conveniently comprise anexternal hand-held remote control unit, which is manually operable bythe patient to control the prosthesis device to achieve a flaccid orerected status of the penis thats to say release or achieve the erectedstatus of the penis. With the wireless remote control the apparatus ofthe invention is conveniently controlled by the patient when he sodesires, which is of great advantage compared to the prior artprocedures. With the remote control the apparatus of the invention isconveniently controlled to adjust the implanted prosthesis device torelease or achieve the erected status of the penis when it is convenientfor the patient.

The remote control may advantageously be capable of obtaininginformation related to important parameters, such as blood pressure orthe pressure against the prosthesis device, and of commanding theoperation device to operate the adjustment device to adjust theprosthesis device in response to obtained information. With the remotecontrol the apparatus of the invention is conveniently controlled toadjust the implanted prosthesis device to release or achieve the erectedstatus of the penis. The adjustment device may control the prosthesisdevice to steplessly change the erection of the penis.

Preferably, the wireless remote control comprises a separate signaltransmitter or receiver and a signal receiver or transmitter implantedin the patient. For example, the signal transmitter and signal receivermay transmit and receive a signal in the form of digital pulses, whichmay comprise a magnetic or electric field. Alternatively, which ispreferred, the signal transmitter and signal receiver may transmit andreceive an electromagnetic wave signal, a sound wave signal or a carrierwave signal for a remote control signal. The receiver may comprise animplanted control unit for controlling the adjustment device in responseto a control signal from the signal transmitter. Any known orconventional signal transmitting or signal receiving means that issuitable for use with a human or mammal patient may be provided as thesignal transmitter or signal receiver.

The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. Where a motor is provided thecontrol unit is adapted to power the motor with energy provided by theenergiser unit in response to a control signal received from the signaltransmitter. The motor may be any type of motor, such as a pneumatic,hydraulic or electric motor and the energiser unit may power the motorwith pressurized gas or liquid, or electric energy, depending on thetype of motor. Where the motor is an electric motor, it may powerpneumatic or hydraulic equipment.

The remote control advantageously comprises wireless energy transferdevice for transferring energy from outside the patient's body to energyconsuming implantable components of the apparatus. The energy transferdevice may comprise said energiser unit is adapted to transform energyfrom the control signal, as it is transmitted to the signal receiver,into electric energy. Where the operation device comprises a motor thewireless energy transfer device is adapted to directly power the motorwith transferred energy.

The energy transferred by the wireless energy transfer device preferablycomprises a signal, suitably a wave signal. The energy transferred bythe wireless energy transfer device may comprise an electric field or amagnetic field or a combination thereof. The signal may be analog ordigital or a combination thereof. The energy transfer device maytransfer the energy from the signal into a direct, pulsating direct oralternating current or a combination thereof.

Any of the above mentioned signals may comprise analog or digitalpulses. The analog or digital signal may comprise a magnetic field or anelectric field or a combination thereof. Where the signal is a wavesignal it may comprise an electromagnetic wave signal, a sound wavesignal or a carrier wave signal for a remote control signal or acombination thereof. Where a carrier signal is used it may be frequency,amplitude or frequency and amplitude modulated.

The apparatus of the invention may comprise an implantable source ofenergy for powering the operation device and/or for energizing otherenergy consuming components of the apparatus, wherein the energy fromthe source of energy is releasable from outside the patient's body.Furthermore, the apparatus may comprise an energy transmission devicefor wireless transmission of energy of a first form and an energytransforming device implantable in the patient for transforming theenergy of the first form into energy of a second form, to be supplied tothe source of energy and/or other implantable energy consuming parts ofthe apparatus. The energy transforming device may transform the wirelessenergy directly or indirectly into energy different than the wirelessenergy for operation of the prosthesis device. Typically, the energy ofthe second form is different than the energy of the first form. Thefunction of the energy transmission device may be different from that ofthe energy transforming device.

An implantable motor or pump for operating the adjustment device may beprovided, wherein the energy transmission device may be adapted totransmit wireless energy in the form of a magnetic field orelectromagnetic waves or field for direct power of the motor or pump, asthe wireless energy is being transmitted. Suitably, the energytransmission device transmits energy by at least one signal separatefrom the above mentioned control signal.

An implantable stabiliser for stabilising the energy of the first orsecond form may be provided. Where the energy of the second formcomprises electric current, the stabiliser suitably comprises at leastone capacitor.

Generally, the source of energy comprises a battery, accumulator,capacitor or a combination thereof.

In accordance with an embodiment of the invention, the apparatuscomprises a control device adapted to produce wireless energy fordirectly powering the operation device and/or for energizing otherenergy consuming components of the apparatus.

It should be understood that the energy consuming parts of the apparatusfor example a motor or pump may be or may not be energised with theunchanged wirelessly transmitted energy as this being transmitted aswell as being or not being energised with energy different than thetransmitted energy for example transformed into electrical energy butstill directly used for energising the energy consuming parts of theapparatus as the transmitted energy is transmitted. Alternatively theenergy consuming parts of the apparatus may be energised from aimplanted source of energy or storage device, which still may be loadedwith wireless energy. In all these aspects it is preferable to be ableto wirelessly control the release of energy and get an feedback of theresult of the performed function of the device. Direct use oftransmitted energy may be unreliable without a feedback what hashappened, has the energy reached it's goal?

Generally, the wireless energy may comprise a wave signal including asound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.

Any of the above mentioned signals may comprise a wave signal includinga sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.

The control device may be adapted to produce wireless energy in the formof a train of energy pulses and the energy transfer device may beadapted to intermittently transfer the train of energy pulses for directuse in connection with the energising of the energy consuming componentsof the apparatus. Alternatively, the control device may be adapted tocontrol the energy transforming device to produce the energy of thesecond form in said train of energy pulses for direct use in connectionwith the operation of the adjustment device. The transferred energypreferably comprises electric energy. An implantable capacitor may beprovided for producing the train of energy pulses.

Where a capacitor is used in any of the above described embodiments itmay have a relatively low capacity, i.e. less than 0.1 μF, in order tobe small and suited for implantation.

Where the operation device comprises an implantable motor or pump foroperating the adjustment device, the energy transfer device may beadapted to directly power the motor or pump with transferred energy, atthe same time as the energy is transferred. Where a pump is used itshould not be a plunger type of pump, because a plunger pump is noisy,but may for example comprise a peristaltic or membrane pump.

As mentioned above the apparatus comprises a wireless remote control fornon-invasively controlling the operation device, which preferably iselectrically powered. Alternatively, the operation device is powered bymagnetic energy, non-magnetic energy, electromagnetic energy,non-electromagnetic energy, kinetic energy, non-kinetic energy, sonicenergy, non-sonic energy, thermal energy or non-thermal energy. However,the operation device may be unpowerable by permanent static magneticenergy. Any other kind of energy, such as electric, electromagneticenergy or a moving permanent magnetic energy, may be conceivable foroperating the adjustment device. As a result, the implanted prosthesisdevice would not be accidentally adjusted if the patient comes close toany permanent magnet. Suitably, the operation device is adapted tonon-invasively operate the adjustment device.

Where the operation device comprises a hydraulic operation device it mayuse hydraulic fluid, the viscosity of which changes when the hydraulicfluid is exposed to energy, preferably electric energy, different thanthermal energy. However, use of hydraulic fluid of the kind having aviscosity that substantially increases when exposed to heat or amagnetic field, i.e. the hydraulic fluid would not become more viscouswhen exposed to heat or influenced by magnetic forces, should beavoided, because external heat sources or heat from the body when thepatient has fever and external magnetic sources might affect theimplanted components of the apparatus.

The adjustment device may be operable to adjust the prosthesis device tosteplessly change the erection of the penis. Furthermore, the adjustmentdevice may be adapted to mechanically adjust the prosthesis device.Alternatively, it may be adapted to hydraulically adjust the prosthesisdevice by using hydraulic means, which is devoid of hydraulic fluid ofthe kind having a viscosity that substantially increases when exposed toheat or a magnetic field.

In accordance with an embodiment of the invention, the apparatuscomprises a control device for controlling the prosthesis device. Thecontrol device may comprise an internal programmable control unitimplantable in the patient and, possibly an external control unitoutside the patient's body for programming the programmable internalcontrol unit. Alternatively, the external control unit may beprogrammable and wirelessly control the prosthesis device. The controldevice may be adapted to produce wireless energy for directly poweringthe operation device and/or for energizing other energy consumingcomponents of the apparatus.

At least one sensor for sensing at least one physical parameter of thepatient may conveniently be implanted in the patient. The sensor maypreferably sense as the physical parameter the horizontal position ofthe patient or may comprise a pressure sensor for sensing the pressureagainst the prosthesis device or other important parameters. Thepressure sensor may be any suitable known or conventional pressuresensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267,4,571,749, 4,407,296 or 3,939,823; or an NPC-102 Medical AngioplastySensor.

Either the internal control unit or the external control unit of thecontrol device may suitably control the prosthesis device to release orachieve erect state of the penis. For safety the prosthesis device mayrelease or achieve erect state of the penis in response to the sensorsensing for example an abnormally high pressure value suitable during.The internal control unit may directly control the prosthesis device inresponse to signals from the sensor.

Wherever magnetic means is utilized according to the invention it maycomprise a permanent magnet and a magnetic material reed switch, orother suitable known or conventional magnetic means.

Where a source of energy is used the control device suitably is operablefrom outside the patient's body for controlling the source of energy torelease energy for use in connection with the operation of theadjustment device, when the adjustment device is implanted. The sourceof energy may be provided external to the patient's body, and thecontrol device may be adapted to control the external source of energyto release wireless energy for use in connection with the operation ofthe adjustment device.

The control device may control the source of energy to release magneticenergy, non-magnetic energy, electromagnetic energy, non-electromagneticenergy, kinetic energy, non-kinetic energy, sonic energy, non-sonicenergy, thermal energy or non-thermal energy, preferably in anon-invasive manner and for a determined time period and/or in adetermined number of energy pulses.

Where the implantable components of the apparatus comprise electricalcomponents they may include at least one or a single voltage levelguard. In this case, the electrical components suitably are devoid ofany current detector and/or charge level detector. Furthermore, theelectrical components may comprise a capacitor or accumulator, whereinthe charge and discharge of the capacitor or accumulator is controlledby use of the voltage level guard. As a result, there is no need for anyimplanted current detector and/or charge level detector for the controlof the capacitor, which makes the apparatus simple and reliable.

In accordance with an advantageous embodiment of the invention, theapparatus comprises an implantable switch for directly or indirectlyswitching the operation of the prosthesis device. The switch may beoperated by the energy supplied by the energy transmission devicementioned above to switch from an off mode, in which the implantablesource of energy mentioned above is not in use, to an on mode, in whichthe source of energy supplies energy for the operation of the prosthesisdevice.

In accordance with an alternative embodiment, the above mentioned aremote control may be employed for controlling the implantable source ofenergy, wherein the switch is operated by the energy supplied by theenergy transmission device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the prosthesis device.

In accordance with another alternative embodiment, the switch isoperated by the energy supplied by the implantable energy transformingdevice mentioned above to switch from an off mode, in which the sourceof energy is not in use, to an on mode, in which the source of energysupplies energy for the operation of the prosthesis device.

In accordance with yet another alternative embodiment, the switch isoperated by the energy supplied by the energy transforming device toswitch from an off mode, in which the remote control is prevented fromcontrolling the source of energy and the source of energy is not in use,to a standby mode, in which the remote control is permitted to controlthe source of energy to supply energy for the operation of theprosthesis device.

Suitably, the prosthesis device is embedded in a soft or gel-likematerial, such as a silicone material having hardness less than 20Shore.

The energy transforming device may be designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.

The adjustment device may be adapted to adjust the prosthesis devicesuch that the prosthesis device provides a predetermined erect statethat is satisfactory for the patient.

Preferable the prosthesis device is adapted to release the erection ofthe penis in response to the implanted sensor sensing ejaculation.

The prosthesis device may be adapted to engage the corpora cavernosa orcrura as a single unit or may comprise two prosthesis members adapted toengage the respective corpora cavernosa or crura.

The adjustment device is preferably adapted to adjust the prosthesisdevice in a non-flux magnetic or non-thermal manner or non-viscositychanging manner, because these would give rise to unreliable function ofthe device. The expression “non-viscosity changing manner” should beunderstood to mean that the adjustment device is not adjusted bychanging the viscosity of the hydraulic fluid used.

All the above described various components, such as the motor, pump andcapacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable. Specifically, the various remote controlfunctions described and all the various methods for supplying energy maybe used in any conceivable combination that is apparent to those skilledin the art.

A method for treating impotence, comprising surgically implanting in thebody of a patient suffering from impotence an corpus cavernosum implantand an adjustable powered operation device, and

-   -   a) when desired to achieve erection,    -   b) in a non-invasively manner adjusting said powered operation        device to    -   c) temporarily adjust the corpus cavernosum implant    -   d) to achieve erected conditions of the penis.

Preferably

-   -   e) placing an adjustable operation devices to engage the corpora        cavernosa implant to achieve erection.    -   f) implanting an hydraulic adjustable reservoir or a        non-inflatable implant in the corpus cavernosum.

Another method for treating impotence comprises:

laparoscopicly implanting in the body of a patient suffering fromimpotence an adjustable operation device which directly engages thenormal tissue in the corpora cavernosa,

placing at least two laparascopical trocars in the human's or animal'sbody,

inserting a dissecting tool through the trocars,

dissecting in the area of the corpora cavernosa, in the penis, and

placing an operable operation device in the dissected area, so that theoperation device adjust an flaccid or erected status of the penis of thepatient, and wherein said operation device preferable is able to performa reversible function and preferable wherein said adjustment device ispowered.

In accordance with the invention, there is further provided a method fortreating male sexual impotence, comprising the steps of:

placing at least two laparascopical trocars in the body of a malepatient suffering from sexual impotence,

inserting a dissecting tool through the trocars and dissecting an areaof the penis and abdominal or retroperitoneal or pelvic surroundings,

placing at least one impotence prosthesis in the corpora cavernosacomprising an adjustment device engaging the penile tissue or theprolongation thereof,

adjusting the adjustment device to achieve erected penile conditions,and

wherein said adjustment device is adjusted in a non-manual manner andpreferably comprising hydraulically adjusting said adjustment devicewhich preferably is powered.

The present invention also provides an implanting method comprisingimplanting a source of energy or transmitting wireless energy to theprosthesis in the patient and providing a control device for controllingthe source of energy from outside the patient's body to supply energy tothe adjustment or operation device. The powered operation device mayalso be manually activated.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIGS. 1A-D are block diagrams of four different principal embodiments ofthe male sexual impotence treatment apparatus according to theinvention.

FIG. 2A-D are cross-sectional views of a pump mechanism according toFIG. 1C, which is designed to pump fluid in opposite directions bymechanically pushing a wall portion in only one direction.

FIG. 3 is a cross-sectional view of a reservoir having a variable volumecontrolled by a remote control motor, in accordance with a particularembodiment of the principal embodiment shown in FIG. 1B or 2B.

FIG. 4 is a cross-sectional view of a reservoir having a variable volumeadjustable by manual manipulation, in accordance with a particularembodiment of the principal embodiment shown in FIG. 1B or 1D.

FIG. 5A is a perspective view of a hydraulic, pneumatic or mechanicalservo system in accordance with a particular embodiment of the principalembodiment shown in FIG. 1D.

FIG. 5B is a cross-sectional view taken along line VB-VB of FIG. 5A.

FIG. 6 is a block diagram illustrating remote control components of thedevice of the invention;

FIG. 7 is a schematic view of exemplary circuitry used for the blockdiagram in FIG. 4;

FIG. 8 is a schematic view of the corpora cavernosa implant placed inthe body of a patient.

FIG. 9 shows a mechanical embodiment of the present invention.

FIG. 10 illustrates the apparatus of the invention in FIG. 9 implantedin a patient.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1A-D is a block diagram of four different embodiments of the malesexual impotence treatment apparatus according to the invention. FIG. 1Ashows a corpus cavernosum penile implant that achieves an erect state ofthe penis when filled with hydraulic fluid. FIG. 1A further shows aseparate reservoir 4, a one way pump 6 and an alternate valve 8. FIG. 1Bshows the band 2 and a fluid supply reservoir 10. FIG. 1C shows the band2, a two way pump 12 and the reservoir 4. FIG. 1D shows a servo systemwith a first closed system controlling a second system. The servo systemcomprises the fluid supply reservoir 10 and a servo reservoir 14. Theservo reservoir 14 controls a larger adjustable reservoir 16 which inconnection with the corpus cavernosum implant 2 varies the volume of acavity in the corpus cavernosum implant, which in turn varies theflaccid or erected conditions of the penis. Such a corpus cavernosumimplant 2 is illustrated schematically in FIG. 8.

FIGS. 2A-D are cross-sectional views of a pump mechanism adapted to pumpfluid in both directions only by mechanically pushing a separate sealingwall portion 18 in one direction. FIG. 2A shows a piston 20 pushedforwards against a spring 22 towards the wall portion 18 and located ina pump housing 24 conducting fluid from a right upper fluid passage 26of the housing 24 to a left fluid passage 28 of the housing 24. A mainvalve 30 is open and a nonreturn valve 32 is closed. FIG. 2B illustratesthe first pump movement, in which the piston 20 has moved forwards andreaches the wall portion 18. FIG. 2C illustrates how the piston 20 movesbackwards by the action of the spring 22. The main valve 30 is nowclosed and the nonreturn valve 32 is open for fluid from the right upperpassage 26. FIG. 1D illustrates how the piston 20 is moved furtherdownwards from its position according to FIG. 2B while pushing the wallportion 18 downwardly against a second spring 34 that is stronger thanspring 22, whereby fluid escapes from a right lower fluid passage 36.When moving the piston 20 backwardly from the position according to FIG.2D, fluid enters the left fluid passage 28 and a valve 38 in the lowerright fluid passage 36 closes.

FIG. 3 is a cross-sectional view of a reservoir 40 defining a chamber42, the size of which is variable and is controlled by a remotecontrolled electric motor 44, in accordance with FIG. 1B or 1D. Thereservoir 40 and the motor 44 are placed in a housing 46. The chamber 42is varied by moving a large wall 48. The wall 48 is secured to a nut 50,which is threaded on a rotatable spindle 52. The spindle 52 is rotatedby the motor 44 via an angular gearing, which comprises two conical gearwheels 54 and 56 in mesh with each other. The motor 44 is powered by abattery 58 placed in the housing 46. An signal receiver 60 forcontrolling the motor 44 is also placed in the housing 46.Alternatively, the battery 58 and the signal receiver 60 may be mountedin a separate place. The motor 44 may also be powered by energytransferred from transmitted signals.

FIG. 4 is a cross-sectional view of a reservoir 62 defining a chamber64, the size of which is variable and is controlled by manualmanipulation. A gable wall portion 66 of an open ended inner cylindricalhousing 68 is adapted to be pushed downwards to fit in a desired lockinggroove 70 of a plurality of locking grooves 70 on the mantle wall of thecylindrical housing 68, to reduce the size of the chamber 64. The innercylindrical housing 68 is suspended by springs 72 and is telescopicallyapplied on an outer cylindrical housing 74. When pushing the innercylindrical housing 68 it moves downwards relative to the outercylindrical housing 74 causing the gable wall portion 66 to release fromthe locking groove 70 and move upwards relative to the inner cylindricalhousing 68. When the inner housing 68 is moved upwardly by the action ofthe springs 72 the size of the chamber 64 is increased.

FIGS. 5A and 5B show a servo means comprising a main ring-shaped fluidreservoir 76 defining a chamber 78, the size of which is variable.Centrally positioned in the main ring-shaped reservoir 76 there is aservo fluid reservoir 80 defining a chamber 82, the size of which isvariable. The chamber 82 of the servo reservoir 80 is substantiallysmaller than the chamber 78 of the main reservoir 76. The two reservoirs76 and 80 are situated between two opposite separate walls 84 and 86,and are secured thereto. When changing the amount of fluid in the servoreservoir 80, the two opposite walls 84,86 are moved towards or awayfrom each other, whereby the size of the chamber 78 of the mainreservoir 76 is changed.

FIG. 6 shows the basic parts of a remote control system of the apparatusof the invention including the electric motor 44 of the embodiment shownin FIG. 3. In this case, the remote control system is based on thetransmission of electromagnetic wave signals, often of high frequenciesin the order of 100 kHz-1 gHz, through the skin 130 of the patient. InFIG. 6, all parts placed to the left of the skin 130 are located outsidethe patient_s body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either increaseor decrease the size of the restriction opening defined by the loop ofthe restriction member 2. The microprocessor starts a command byapplying a high frequency signal on the antenna 132. After a short time,when the signal has energized the implanted parts of the control system,commands are sent to increase or decrease the size of the restrictionopening of the restriction member 2 in predefined steps. The commandsare sent as digital packets in the form illustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new increase or decrease step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energizer unit 126 draws energy fromthe high frequency electromagnetic wave signal received by the receivingantenna 134. The energizer unit 126 stores the energy in a power supply,such as a large capacitor, powers the control unit 138 and powers theelectric motor 44 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergizer unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 44 to either increase or decrease theerected or flaccid conditions of the penis 2 depending on the receivedcommand code.

Alternatively, the energy stored in the power supply of the energizerunit may only be used for powering a switch, and the energy for poweringthe motor 44 may be obtained from another implanted power source ofrelatively high capacity, for example a battery. In this case the switchis adapted to connect the battery to the control unit 138 in an on modewhen the switch is powered by the power supply and to keep the batterydisconnected from the control unit in a standby mode when said switch isunpowered.

With reference to FIG. 7, the remote control system schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theimpotence treatment prosthesis apparatus. The power amplifier 150amplifies the signals and sends them to the external signal transmittingantenna 132. The antenna 132 is connected in parallel with a capacitor152 to form a resonant circuit tuned to the frequency generated by thesignal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 168 connected in series with aresistor 170 connected in series with a capacitor 172 connected inseries with the resistor 168 via ground, and a capacitor 174, oneterminal of which is connected between the resistors 168,170 and theother terminal of which is connected between the diode 166 and thecircuit formed by the capacitor 162 and resistor 164. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 176 thatdecodes the digital information and controls the motor 44 via anH-bridge 178 comprising transistors 180, 182, 184 and 186. The motor 44can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 44,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor44.

FIG. 8 is a schematic view of the corpora cavernosa implant placed inthe body of a patient. The corpus cavernosum implant (2) is suppliedhydraulic fluid through the conduit (206) from the reservoir (4). Fluidis evacuated from the reservoir (4) the corpus cavernosum implant (2) isfilled with hydraulic fluid, thus achieving erected condition of thepenis (208). When erection is desired the remote control (210) suppliescommand signal and wireless energy transmission from the transmittingantenna (132). The control unit (202) includes an energy transfer devicefor supplying energy to the energy consuming parts of the apparatus. Thesensor (212) may receive information related to the corpus cavernosumimplant (2) and send feed-back signals to the control unit (202). Thecontrol unit (202) may then take corrective actions and control thereservoir (4) to adjust the amount of fluid in the reservoir (4) andthereby the corpus cavernosum implant (2).

FIG. 9 shows a mechanical embodiment of the present invention. In thisembodiment a motor (304) receiving energy from the electrical wires(308) from the control unit (202). The motor (304) is through a wheel(310) controlling a telescope mechanical construction with a spring(302) and circular tubes in different sizes (306). When the motor (304)release a wire (312) will the spring (302) activate the tubes ofdifferent sizes (306) to achieve erected condition of the penis (208).

FIG. 10 illustrates the apparatus of the invention in FIG. 9 implantedin a patient. This schematic views shows the control unit (202) and themechanical spring system (302) and how to achieve an erected conditionof the penis (208).

There are a number of conceivable alternative embodiments of theinvention that give the same result as the above-described embodiments.For example, the microprocessor of the external and implanted,respectively, control units may be replaced by discrete components. Thepower amplifier of the external control unit may be omitted if thesignals generated by the signal generator are strong enough. Therefore,the invention is to be accorded the broadest interpretation of theappended claims to encompass all equivalent structures and assemblies.

1-162. (canceled)
 163. A male sexual impotence treatment apparatus,comprising: an adjustable prosthesis device implantable in the corporacavernosa or other parts of a male impotent patient's penile tissue animplantable hydraulic adjustment device for adjusting the prosthesisdevice to temporarily achieve erect state of the penis, an implantableoperation device for operating the hydraulic adjustment device, areservoir implantable in the patient and defining a chamber containinghydraulic fluid, and a conduit providing fluid connection between thechamber and the hydraulic adjustment device, the conduit permitting freeflow of hydraulic fluid in both directions in the conduit, the reservoirincluding first and second wall portions, wherein the operation deviceis adapted to provide relative displacement between the first and secondwall portions of the reservoir to change the volume of the chamber todistribute hydraulic fluid through the conduit between the chamber ofthe reservoir and the hydraulic adjustment device, to operate thehydraulic adjustment device to adjust the prosthesis device.
 164. Anapparatus according to claim 163, wherein the chamber of the reservoir,the conduit and the hydraulic adjustment device contain a predeterminedamount of hydraulic fluid.
 165. An apparatus according to claim 164,wherein the adjustment device comprises an expandable cavity in theprosthesis device, the corpora cavernosa being filled upon expansion ofthe cavity and released upon emptying of the cavity, and the operationdevice is adapted to distribute hydraulic fluid from the chamber of thereservoir to expand the cavity, and to distribute hydraulic fluid fromthe cavity to the chamber of the reservoir to contract the cavity. 166.An apparatus according to claim 165, wherein the operation device isadapted to distribute hydraulic fluid from the chamber of the reservoirto expand the cavity to achieve erect state of the penis, and todistribute hydraulic fluid from the cavity to the chamber of thereservoir to contract the cavity to achieve flaccid state of the penis.167. An apparatus according to claim 165, wherein the operation deviceis adapted to provide said relative displacement in response to thepressure in the reservoir.
 168. An apparatus according to claim 167,wherein the operation device comprises a pressure controlled hydraulicoperation device.
 169. An apparatus according to claim 168, furthercomprising an alarm adapted to generate an alarm signal in response tothe lapse of a predetermined time period during which the pressurecontrolling the hydraulic operation device exceeds a predetermined highvalue.
 170. An apparatus according to claim 165, wherein the first andsecond wall portions of the reservoir are displaceable relative to eachother by magnetic means, hydraulic means, or electric control means, ora combination thereof.
 171. An apparatus according to claim 165, whereinthe operation device is adapted to distribute fluid from the reservoirto the cavity of the prosthesis device in response to a predeterminedfirst displacement of the first wall portion of the reservoir relativeto the second wall portion of the reservoir and to distribute fluid fromthe cavity to the reservoir in response to a predetermined seconddisplacement of the first wall portion relative to the second wallportion.
 172. An apparatus according to claim 163, wherein the operationdevice comprises a servo means.
 173. An apparatus according to claim163, wherein the operation device comprises a reverse servo.
 174. Anapparatus according to claim 163, wherein the operation device ispowered.
 175. An apparatus according to claim 163, wherein the operationdevice is manually operated.
 176. An apparatus according to claim 163,wherein the servo means comprises a motor, preferably an electric motor.177. An apparatus according to claim 176, wherein the motor isreversible.
 178. An apparatus according to claim 176, further comprisinga gearing connected between the motor and the adjustment device.
 179. Anapparatus according to claim 163, wherein the operation device comprisesa reverse servo.
 180. An apparatus according to claim 173, wherein thereverse servo is adapted to provide said relative displacement betweenthe first and second wall portions of the reservoir.
 181. An apparatusaccording to claim 180, wherein the reverse servo device is adapted toprovide said relative displacement in response to the pressure in thereservoir.
 182. An apparatus according to claim 172, wherein the servomeans comprises a pressure controlled servo means.
 183. An apparatusaccording to claim 182, further comprising an alarm adapted to generatean alarm signal in response to the lapse of a predetermined time periodduring which the pressure controlling the servo means exceeds apredetermined high value.
 184. An apparatus according to claim 173,wherein the reverse servo comprises magnetic means, electric means ormanual manipulation means or a combination thereof.
 185. An apparatusaccording to claim 173, wherein the reverse servo comprises hydraulicmeans.
 186. An apparatus according to claim 185, wherein the reverseservo further comprises a servo reservoir defining a chamber containingservo fluid, and the operation device comprise first and second wallportions of the servo reservoir, which are displaceable relative to eachother to change the volume of the chamber of the servo reservoir. 187.An apparatus according to claim 186, wherein the first and second wallportions of the servo reservoir are displaceable relative to each otherby magnetic means, hydraulic means, or electric control means.
 188. Anapparatus according to claim 185, wherein the reverse servo comprises aservo reservoir and a fluid supply reservoir connected in a closedsystem and containing a further predetermined amount of fluid.
 189. Anapparatus according to claim 188, wherein the fluid supply reservoirdefines a chamber for the further predetermined amount of fluid and theoperation device is adapted to change the volume of the chamber of thefluid supply reservoir and thereby control the amount of fluid in theservo reservoir.
 190. An apparatus according to claim 189, wherein thefluid supply reservoir comprises first and second wall portions, whichare displaceable relative to each other to change the volume of thechamber of the fluid supply reservoir.
 191. An apparatus according toclaim 190, wherein the fluid supply reservoir increases the amount offluid in the servo reservoir in response to a predetermined firstdisplacement of the first wall portion of the fluid supply reservoirrelative to the second wall portion of the fluid supply reservoir anddecreases the amount of fluid in the servo reservoir in response to apredetermined second displacement of the first wall portion of the fluidsupply reservoir relative to the second wall portion of the fluid supplyreservoir.
 192. An apparatus according to claim 163, wherein theoperation device comprises a motor.
 193. An apparatus according to claim166, further comprising an injection port subcutaneously implantable inthe patient and in fluid communication with the chamber.
 194. Anapparatus according to claim 193, wherein the injection port isintegrated in the reservoir.
 195. An apparatus according to claim 163,wherein the adjustment device or prosthesis device is non-inflatable.196. An apparatus according to claim 195, wherein the adjustment devicehydraulically adjusts the non-inflatable prosthesis device.
 197. Anapparatus according to claim 163, further comprising a wireless remotecontrol for non-invasively controlling the operation device.
 198. Anapparatus according to claim 197, wherein the remote control comprisesan external wireless hand-held remote control unit which is manuallyoperable by the patient to control the prosthesis device to cause erectstate of the penis.
 199. An apparatus according to claim 197, whereinthe remote control comprises an external signal, receiver or transceiverand a signal receiver, transmitter or transceiver implantable in thepatient.
 200. An apparatus according to claim 199, wherein the signalreceiver and/or transmitter comprises a control unit adapted to controlthe operation device in response to a control signal received from thesignal transmitter.
 201. An apparatus according to claim 200, furthercomprising an implantable energizer unit for providing energy to energyconsuming implantable components of the apparatus.
 202. An apparatusaccording to claim 201, wherein the operation device comprises a motorfor operating the adjustment device.
 203. An apparatus according toclaim 202, wherein the control unit is adapted to power the motor withenergy provided by the energizer unit in response to a control signalreceived from the signal transmitter.
 204. An apparatus according toclaim 197, wherein the remote control comprises wireless energy transfermeans for transferring energy from outside the patient's body to energyconsuming implantable components of the apparatus.
 205. An apparatusaccording to claim 201, wherein the energy transfer means comprises animplantable energizer unit, which is adapted to transform energy fromthe control signal, as it is transmitted to the signal receiver), intoelectric energy.
 206. An apparatus according to claim 204, wherein theoperation device comprises a motor, and the wireless energy transfermeans is adapted to directly power the motor with transferred energy.207. An apparatus according to claim 205, wherein the energy transferredby the wireless energy transfer means comprises a signal.
 208. Anapparatus according to claim 207, wherein the signal comprises a wavesignal.
 209. An apparatus according to claim 205, wherein the energytransferred by the wireless energy transfer means comprises an electricfield or a magnetic field or a combination thereof.
 210. An apparatusaccording to claim 207, wherein the signal is analog or digital or acombination thereof.
 211. An apparatus according to claim 199, whereinthe signal transmitter and signal receiver are adapted to transmit andreceive an analog or digital signal or a combination thereof.
 212. Anapparatus according to claim 210, wherein the signal comprises analog ordigital pulses.
 213. An apparatus according to claim 210, wherein theanalog or digital signal comprises a magnetic field or an electric fieldor a combination thereof.
 214. An apparatus according to claim 199,wherein the signal transmitter and signal receiver are adapted totransmit and receive a wave signal.
 215. An apparatus according to claim207, wherein the wave signal comprises an electromagnetic wave signal, asound wave signal or a carrier wave signal for a remote control signalor a combination thereof.
 216. An apparatus according to claim 215,wherein the carrier signal is frequency, amplitude or frequency andamplitude modulated.
 217. An apparatus according to claim 207, whereinthe energy transfer means transfers the energy from the signal into adirect, pulsating direct or alternating current or a combinationthereof.
 218. An apparatus according to claim 197, wherein the remotecontrol is capable of obtaining information related to importantparameters of the apparatus from inside the patient's body and ofcommanding the adjustment device to adjust the prosthesis device inresponse to obtained information.
 219. An apparatus according to claim197, wherein the remote control is capable of obtaining informationrelated to the prosthesis device and of commanding the adjustment deviceto adjust the prosthesis device in response to obtained information.220. An apparatus according to claim 163, further comprising animplantable source of energy for powering the operation device and/orfor energizing other energy consuming components of the apparatus,wherein the energy from the source of energy is releasable from outsidethe patient's body.
 221. An apparatus according to claim 163, furthercomprising an energy transmission device for wireless transmission ofenergy.
 222. An apparatus according to claim 220, further comprising anenergy transmission device for wireless transmission of energy of afirst form, and an energy transforming device implantable in the patientfor transforming the energy of the first form into energy of a secondform, to be supplied to the source of energy and/or other implantableenergy consuming parts of the apparatus.
 223. An apparatus according toclaim 222, wherein the energy of the second form is different than theenergy of the first form.
 224. An apparatus according to claim 222,wherein the energy transmission device functions different from theenergy transforming device.
 225. An apparatus according to claim 221,wherein the operation device comprises an implantable motor and theenergy transmission device is adapted to transmit wireless energy in theform of an magnetic field or electromagnetic waves or field for directpower of the motor, as the wireless energy is being transmitted.
 226. Anapparatus according to claim 200, wherein the energy transmission devicetransmits energy by at least one signal separate from the controlsignal.
 227. An apparatus according to claim 222, further comprising animplantable stabiliser for stabilising the energy of the first or secondform.
 228. An apparatus according to claim 227, wherein the energy ofthe second form comprises electric current and the stabiliser comprisesat least one capacitor.
 229. An apparatus according to claim 220,wherein the source of energy comprises a battery, accumulator, capacitoror a combination thereof.
 230. An apparatus according to claim 163,further comprising a control device adapted to produce wireless energyfor directly powering the operation device and/or for energizing otherenergy consuming components of the apparatus.
 231. An apparatusaccording to claim 163, further comprising an implantable energytransforming device for transforming wireless energy directly orindirectly into energy different than the wireless energy for operationof the prosthesis device.
 232. An apparatus according to claim 230,wherein the wireless energy comprises a wave signal including a soundwave signal, an ultrasound wave signal, an electromagnetic wave signal,an infrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal or a gamma radiation signal.
 233. An apparatusaccording to claim 163, further comprising an energy transfer means forwireless transfer of energy from outside the patient's body to theoperation device or adjustment device and/or other energy consumingimplantable components of the apparatus.
 234. An apparatus according toclaim 230, wherein the control device is adapted to produce wirelessenergy in the form of a train of energy pulses.
 235. An apparatusaccording to claim 204, wherein the energy transfer means is adapted tointermittently transfer the energy in the form of a train of energypulses for direct use in connection with the energising of the energyconsuming components of the apparatus.
 236. An apparatus according toclaim 230, further comprising an energy transmission device for wirelesstransmission of energy of a first form, and an energy transformingdevice implantable in the patient for transforming the energy of thefirst form into energy of a second form, wherein the control device isadapted to control the energy transforming device to produce the energyof the second form in a train of energy pulses for direct use inconnection with the operation of the adjustment device.
 237. Anapparatus according to claim 235, wherein the energy transfer means isadapted to transfer electric energy, and further comprising animplantable capacitor for producing the train of energy pulses.
 238. Anapparatus according to claim 237, wherein the capacitor has a capacityless than 0.1 μF.
 239. An apparatus according to claim 233, wherein theoperation device comprises an implantable motor and the energy transfermeans is adapted to directly power the motor with transferred energy.240. An apparatus according to claim 163, further comprising animplantable source of energy for energizing energy consuming parts ofthe apparatus, wherein the source of energy is loaded with wirelessenergy.
 241. An apparatus according to claim 198, further comprising awireless remote control for non-invasively controlling the operationdevice.
 242. An apparatus according to claim 163, wherein the operationdevice is electrically powered.
 243. An apparatus according to claim163, wherein the operation device is unpowerable by static permanentmagnetic energy.
 244. An apparatus according to claim 163, wherein theoperation device is adapted to non-invasively operate the adjustmentdevice.
 245. An apparatus according to claim 163, wherein the adjustmentdevice is operable to adjust the prosthesis device to steplessly changethe erect state of the penis.
 246. An apparatus according to claim 163,wherein the operation device comprises a hydraulic operation devicewhich uses hydraulic fluid, the viscosity of which changes when thehydraulic fluid is exposed to energy different than thermal energy. 247.An apparatus according to claim 242, wherein the viscosity of thehydraulic fluid changes when the fluid is exposed to electric energy.248. An apparatus according to claim 163, further comprising a controldevice for controlling the prosthesis device.
 249. An apparatusaccording to claim 248, wherein the control device comprises an internalcontrol unit implantable in the patient for controlling the prosthesisdevice.
 250. An apparatus according to claim 249, wherein the internalcontrol unit is programmable.
 251. An apparatus according to claim 250,wherein the control device comprises an external control unit outsidethe patient's body, the implantable internal control unit beingprogrammable by the external control unit.
 252. An apparatus accordingto claim 248, wherein the control device comprises an external controlunit outside the patient's body for wirelessly controlling theprosthesis device.
 253. An apparatus according to claim 252, wherein theexternal control unit is programmable.
 254. An apparatus according toclaim 163, further comprising at least one implantable sensor forsensing at least one physical parameter of the patient.
 255. Anapparatus according to claim 254, wherein the sensor is adapted todirectly or indirectly sense as the physical parameter the horizontalposition of the patient.
 256. An apparatus according to claim 254,wherein the sensor comprises a pressure sensor for directly orindirectly sensing as the physical parameter the pressure against theprosthesis device or part of the human body.
 257. An apparatus accordingto claim 256, wherein the adjustment device is adapted to change theprosthesis device in corpora cavernosa in response to the pressuresensor sensing a predetermined pressure.
 258. An apparatus according toclaim 163, further comprising a control device for controlling theprosthesis device in response to signals from the sensor.
 259. Anapparatus according to claim 258, wherein the control device comprisesan internal control unit implantable in the patient and directlycontrolling the prosthesis device in response to signals from thesensor.
 260. An apparatus according to claim 259, wherein the controldevice comprises an external control unit outside the patient's body forcontrolling the prosthesis device in response to signals from thesensor.
 261. An apparatus according to claim 259, wherein the controldevice comprises an external control unit outside the patient's body formanually controlling the prosthesis device in response to informationfrom the sensor.
 262. An apparatus according to claim 248, furthercomprising an implantable source of energy, wherein the control deviceis operable from outside the patient's body for controlling the sourceof energy to release energy for use in connection with the operation ofthe prosthesis device, when the prosthesis device is implanted.
 263. Anapparatus according to claim 248, further comprising a source of energyintended to be external to the patient's body, and the control device isadapted to control the external source of energy to release wirelessenergy for use in connection with the operation of the prosthesisdevice.
 264. An apparatus according to claim 262, wherein the controldevice controls the source of energy to release magnetic energy,non-magnetic energy, electromagnetic energy, non-electromagnetic energy,kinetic energy, non-kinetic energy, sonic energy, non-sonic energy,thermal energy or non-thermal energy.
 265. An apparatus according toclaim 163, wherein the operation device is powered by magnetic energy,non-magnetic energy, electromagnetic energy, non-electromagnetic energy,kinetic energy, non-kinetic energy, sonic energy, non-sonic energy,thermal energy or non-thermal energy.
 266. An apparatus according toclaim 262, wherein the control device controls the source of energy torelease energy for a determined time period.
 267. An apparatus accordingto claim 262, wherein the control device controls the source of energyto release energy in a determined number of energy pulses.
 268. Anapparatus according to claim 262, wherein the control device is adaptedto control the source of energy to release energy in a non-invasivemanner.
 269. An apparatus according to claim 163, further comprisingimplantable electrical components including at least one voltage levelguard.
 270. An apparatus according to claim 163, further comprisingimplantable electrical components including a single voltage levelguard.
 271. An apparatus according to claim 269, wherein the electricalcomponents are devoid of any current detector and/or charge leveldetector.
 272. An apparatus according to claim 220, further comprisingan implantable capacitor or accumulator, wherein the charge or dischargeof the capacitor or accumulator is controlled by use of the voltagelevel guard.
 273. An apparatus according to claim 200, wherein thecontrol signal comprises a wave signal including a sound wave signal, anultrasound wave signal, an electromagnetic wave signal, an infraredlight signal, a visible light signal, an ultra violet light signal, alaser light signal, a micro wave signal, a radio wave signal, an x-rayradiation signal or a gamma radiation signal.
 274. An apparatusaccording to claim 163, further comprising a switch implantable in thepatient for directly or indirectly switching the operation of theprosthesis device.
 275. An apparatus according to claim 274, furthercomprising a source of energy implantable in the patient for supplyingenergy for the operation of the prosthesis device, wherein the switch isoperated by the energy supplied by the energy transmission device toswitch from an off mode, in which the source of energy is not in use, toan on mode, in which the source of energy supplies energy for theoperation of the prosthesis device.
 276. An apparatus according to claim274, further comprising a source of energy implantable in the patientfor supplying energy for the operation of the prosthesis device, and aremote control for controlling the supply of energy of the implantablesource of energy, wherein the switch is operated by the energy suppliedby the energy transmission device to switch from an off mode, in whichthe remote control is prevented from controlling the source of energyand the source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the prosthesis device.
 277. An apparatusaccording to claim 274, further comprising a source of energyimplantable in the patient for supplying energy for the operation of theprosthesis device, wherein the switch is operated by the energy suppliedby the energy transforming device to switch from an off mode, in whichthe source of energy is not in use, to an on mode, in which the sourceof energy supplies energy for the operation of the prosthesis device.278. An apparatus according to claim 274, further comprising a source ofenergy implantable in the patient for supplying energy for the operationof the prosthesis device, and a remote control for controlling thesupply of energy of the implantable source of energy, wherein the switchis operated by the energy supplied by the energy transforming device toswitch from an off mode, in which the remote control is prevented fromcontrolling the source of energy and the source of energy is not in use,to a standby mode, in which the remote control is permitted to controlthe source of energy to supply energy for the operation of theprosthesis device.
 279. An apparatus according to claim 163, wherein theprosthesis device is operable to perform a reversible function.
 280. Anapparatus according to claim 279, further comprising a reversing deviceimplantable in the patient for reversing the function performed by theprosthesis device.
 281. An apparatus according to claim 280, furthercomprising a control device for controlling the reversing device toreverse the function performed by the prosthesis device.
 282. Anapparatus according to claim 280, wherein the reversing device compriseshydraulic means including a valve for shifting the flow direction of aflowing fluid in the hydraulic means.
 283. An apparatus according toclaim 280, wherein the reversing device comprises a mechanical reversingdevice.
 284. An apparatus according to claim 280, wherein the reversingdevice comprises a switch.
 285. An apparatus according to claim 284,wherein the switch of the reversing device is operable by the releasedenergy.
 286. An apparatus according to claim 285, wherein the controldevice controls the operation of the switch of the reversing device byshifting polarity of the released energy supplied to the switch.
 287. Anapparatus according to claim 280, wherein the operation device comprisesa motor, and the reversing device reverses the motor.
 288. An apparatusaccording to claim 163, wherein the prosthesis device is embedded in asoft or gel-like material.
 289. An apparatus according to claim 288,wherein the prosthesis device is embedded in a silicone material havinghardness less than 20 Shore.
 290. An apparatus according to claim 222,wherein the energy transforming device is designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.
 291. An apparatus according to claim 258, wherein theprosthesis device is adapted to release the erection of the penis inresponse to the sensor sensing ejaculation.
 292. An apparatus accordingto claim 163, wherein the prosthesis device is adapted to engage thecorpora cavernosa or crura as a single unit.
 293. An apparatus accordingto claim 163, wherein the prosthesis device further comprises twoprosthesis members adapted to engage the respective corpora cavernosa orcrura.
 294. An apparatus according to claim 163, wherein the adjustmentdevice is adapted to adjust the prosthesis device such that theprosthesis device provides a predetermined adjustment of the corporacavernosa or crura or the prolongations thereof that is satisfactory forthe patient.
 295. An apparatus according to claim 163, wherein theadjustment device is adapted to adjust the prosthesis device in anon-flux magnetic or non-thermal manner or non-viscosity changingmanner.
 296. An apparatus according to claim 262, wherein the source ofenergy is loaded with wireless energy.